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New treatment option for Non Small Cell Lung Cancer
Official title Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
ClinicalTrials.gov ID: NCT04875585
What this study is testing
What is neoadjuvant therapy with Pembrolizumab/Lenvatinib?
neoadjuvant therapy with Pembrolizumab/Lenvatinib is an investigational medicine, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary aim of this single arm, phase II study is to determine the efficacy of the combination therapy Pembrolizumab/Lenvatinib regarding the rate of major pathological response (MPR-Rate). The investigators expect to improve the MPR-Rate of 20% in Anti-PD1/-PD-L1 monotherapy (observed in recent trials) to a MPR-Rate of 40% with the combination therapy Pembrolizumab/Lenvatinib.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male/female participants ≥18 years of age
- Histologically confirmed primary diagnosis of resectable NSCLC, stages IA3-IIIA (max. single station N2).
- Measurable disease based on RECIST 1.1.
- Male participants must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120...
- Female participants are eligible to participate if not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions...
You likely can't join if
- A woman with child-bearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to inclusion (see Appendix 3). If the...
- Uncontrolled blood pressure (systolic BP\>160mmHg or diastolic BP \>95mmHg) despite an optimized regimen of antihypertensive medication.
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina...
- History of prolonged QT syndrome, or family member with prolonged QT syndrome
- QTc interval \>490 msec when 3 consecutive ECG values are averaged
- Bleeding and/or thrombotic disorders and/or people at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels...
See the full eligibility criteria
Who can join
- Male/female participants ≥18 years of age
- Histologically confirmed primary diagnosis of resectable NSCLC, stages IA3-IIIA (max. single station N2).
- Measurable disease based on RECIST 1.1.
- Male participants must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 additional days after the last dose of study treatment and refrain from...
- Female participants are eligible to participate if not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days after the last dose of study treatment.
- Written informed consent provided
- ECOG performance status of 0 to 1
- Adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment.
What rules you out
- A woman with child-bearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to inclusion (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum...
- Uncontrolled blood pressure (systolic BP\>160mmHg or diastolic BP \>95mmHg) despite an optimized regimen of antihypertensive medication.
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of...
- History of prolonged QT syndrome, or family member with prolonged QT syndrome
- QTc interval \>490 msec when 3 consecutive ECG values are averaged
- Bleeding and/or thrombotic disorders and/or people at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage...
- people having \> 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \<1 g/24 hours.
- Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (eg, CTLA-4, OX 40, CD137).
- Patient has received prior systemic anti-cancer therapy for the newly diagnosed NSCLC including investigational agents.
- Patient has received prior radiotherapy for the newly diagnosed NSCLC.
- Patient has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken...
- Patient is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who...
- Diagnosis of immunodeficiency and/or patient is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to...
- Known additional malignancy that is progressing.
- Known history of severe (≥Grade 3) allergic or hypersensitivity reactions to Pembrolizumab or Lenvatinib and/or any of their excipients.
- Known active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg. thyroxine...
- History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Active infection requiring systemic therapy.
- Infection with Human Immunodeficiency Virus (HIV).
- Infection with Hepatitis B and/or Hepatitis C
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Patient has received prior surgery therapy for the newly diagnosed NSCLC.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Innsbruck, Tyrol, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Innsbruck, Tyrol, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.